KR101704153B1 - Medicament delivery device - Google Patents

Abstract

The present invention relates to a housing (2, 3, 4, 5); The container holder 10 is configured to receive the drug container 12 and the drug container 12 includes a needle 13 attached to one end of the drug container, The container holder (10) having a stopper sealingly and slidably arranged within the drug container (12) at an end thereof; A driving unit comprising a plunger rod (60) and plunger driving means (50, 70), wherein the driving unit further comprises a first energy accumulating member (40), and the plunger driving means 1 drive unit, operatively associated with an energy accumulation member (40); And scan indication mechanisms 182,204 and 212. The scan indication mechanisms 182,204 and 212 comprise tactile signal elements 204 and 212 and a drive mechanism 182 for driving the tactile signal elements, The drive mechanism 182 relates to a scanning device including the scan indicating mechanism 182, 204, 212, which is coupled to the plunger drive means 50, 70.

Description

[0001] MEDICAMENT DELIVERY DEVICE [0002]

The present invention relates to a scanning device with several automatic functions, such as automatic infiltration, automatic injection, and automatic safety means for preventing accidental needle pricking, and particularly relates to a device for handling fluid in the form of a fluid having a high viscosity To an injection device that can be used to perform the operation.

The present invention relates to a scanning device for injecting a drug in the form of a fluid having a high viscosity. Having a high viscosity means that these devices require a large force to pressurize the fluid through the needle when injecting the drug it means.

Auto-injectors or pen-injectors have been on the market for many years. One of the first auto-injectors was developed during the exhibition, which was activated by pressing the syringe against the body part to activate it. The primary concern was to allow the drug to be injected as soon as possible without much concern for the patient or for handling safety aspects. In recent years, some drugs have been developed to be injected by the patient himself. Thus, depending on the intended use and type of drug, it may be desirable to have a variety of automated functions that facilitate the injection of the drug in a reliable and safe manner for the patient, and even for skilled personnel, such as physicians and nurses Injection devices were also developed.

An auto-syringe device with an additional automated scanning function includes a housing, a spirally wound compression spring acting on the plunger rod which eventually acts on a stopper within the drug container to release the drug through the needle attached to the container Often included. Usually, one end of the spring often abuts the inner end surface of the housing, which means that the housing must be dimensioned to match the force of the spring. If a fluid with a high viscosity is to be injected using an auto-injector, a large force is required to release the drug through the fine needle. Thus, the spring becomes very large with respect to both the diameter of the wound springs and also the diameter of the threads of the wire. The size of these springs means that the device will grow, and for some applications and customers, such a device size is not acceptable.

Also, particularly when the injection of the drug takes a long time, for example when a high viscosity liquid is injected and / or a needle with a small diameter is used, the user of the injection device wants to know whether the injection is still in progress. In other words, the user self-administering the drug needs to be aware of when the injection is complete and when it is safe to remove the syringe from the injection site.

International Publication WO 2004/020028 describes a scanning device having a closed scale band. When administering the product, the dosage required by rotating the spin button is set in the injection device. This shifts the scale band according to the dosage setting, and once the dose setting rotation is complete, the corresponding dosage unit can be read out through a window. However, such a scale band for dose indication does not show the progress of the injection.

A scanning device having a band type indicator as proposed in International Publication WO 2004/020028, however, is complicated to assemble. Moreover, the movement of the band is visible to the user only from one direction or viewing angle (or viewing angle of a small band). In addition, slow scanning may be difficult to detect by the user.

Another means of information about the progress of the scan is by tactile means. Document WO 2008/083875 discloses a medical delivery device comprising tactile information means capable of providing vibrations to the device, for example during a scan cycle. The vibration is preferably generated by an imbalanced member. The tactile information member of the device is somewhat bulky, especially since it is usually limited in space when it is to be fitted into a rather small device. In addition, vibration of the entire device may be undesirable in some cases and, in some patients, may require finer tactile information.

In order to overcome one or several of the problems mentioned above, an injection device according to independent claim 1 is provided.

Additional aspects, improvements and modifications are disclosed in the dependent claims, the drawings and the detailed description.

In the present application, when the term "distal" is used, it refers to the direction away from the dose delivery site. When the term " distal part / end "is used, it refers to the part / end of the delivery device located farthest away from the dose delivery site, or the part / end of its member.

Correspondingly, when the term "proximal" is used, it refers to the direction toward the dose delivery site. When the term "proximal part / end " is used, it refers to the part / end of the delivery device located closest to the dose delivery site, or the part / end of its absence.

The injection device according to the present invention may comprise one part or several interconnections and attached parts, for example a housing, which may be a proximal housing part, a distal housing part and possibly an intermediate housing part.

One of the housing parts may preferably comprise a container holder arranged in the proximal housing part when several housing parts are provided in the housing, preferably the device. The container holder is configured to receive a medicament container, the medicament container having a needle attached to one end thereof and a stopper (not shown) sealingly and slidably arranged inside the drug container at the other end stopper.

The apparatus may further comprise a plunger rod arranged to act on a stopper of the drug container, and a plunger driving means capable of driving the plunger rod in the proximal direction to move the stopper. The plunger drive means can be slidably arranged with respect to the plunger rod and can be rotationally locked with respect to the plunger rod as well as rotatable with respect to the housing.

The drive unit may further include a first energy accumulating member arranged inside the housing of the scanning apparatus and configured to store and store energy. The energy accumulating member may be any kind of spring that can be tensioned to provide energy when the plunger driving means is released. Preferably, the first energy accumulating member is a spiral wound spring. The plunger driving means is preferably operatively associated with the first energy accumulating member.

The plunger drive means is preferably releasable such that the output torque from the first energy accumulation member causes the plunger drive means to rotate and the plunger rod is urged toward the proximal end of the syringe device to cause the scan to be performed .

According to a main aspect of the present invention, the apparatus is arranged to have a scan indicator mechanism configured to display a progress of the scan to a user. The scan indicating mechanism may preferably include a tactile signal element and a drive mechanism for driving the tactile signal element.

A drive mechanism may be coupled to the plunger drive means at a distal end of the plunger drive means, wherein the scan indicia mechanism is configured such that the progress of the scan in response to the tactile signal member projecting out of the distal end surface of the housing Can be arranged to be felt. Thus, the tactile signal member provides information to the user through a finger that rests on, for example, the distal end of the device or other part of the user's hand, depending on how the user grasps the device during the scan.

According to one preferred solution, the tactile signal element may comprise at least one distally directed protrusion arranged to extend through at least one passage arranged in the end surface of the housing. In this way, the extension of the protrusion provides reliable information as to the progress of the injection. Preferably, the scanning device is also a rotational driving mechanism in which the driving mechanism is rotationally locked to the driving means such that rotation of the rotational driving mechanism during scanning drives the tactile signal member in a distal direction to indicate progress of the scanning Lt; / RTI > In this manner, it is possible to utilize the rotational motion of the drive means, which is transmitted to the rotational drive mechanism to rotationally drive the tactile signal member.

In order to transmit rotational motion to the tactile signal member, the tactile signal member may be arranged to have a threaded segment designed to cooperate with a corresponding threaded segment on the rotational drive mechanism for driving the tactile signal member. The threaded engagement provides a natural and reliable driving force between the components.

When providing the desired pre-determined tactile information, various components of the device may be modified and designed to achieve certain characteristics for the signal member to inform the user of the progress of the scan. The pitch of the threaded segment may be configured to achieve a predetermined displacement rate of the tactile signal member. The length of the protrusion may be varied to achieve a predetermined timing or tactile experience with respect to the progress of the scan. Similarly, the initial and / or final position of the tactile signal member with respect to the distal end surface of the device may be configured to achieve a desired predetermined characteristic.

For example, the length and / or position of the protrusions of the signal member with respect to the distal end surface may be selected to signal that they are ready for use, e.g., the device is already slightly protruding before the scanning sequence. The pitch can then be selected such that the protrusions do not extend so much during the scan sequence, but only enough to provide tactile information that the scan is in progress.

On the other hand, the pitch, length and / or position of the signal member may be selected to indicate the end of the scan, as it protrudes only at the end or end of the scan sequence.

In addition to the tactile signal, the device according to the invention can also be arranged to have an auditory signal element. According to an aspect of the present invention, the rotation driving mechanism may further include an auditory signal member configured to audibly display the progress of the scan to the user so that the progress of the scan is audible to the user. This feature provides the device with additional sources of information that can increase overall functionality and responsiveness. For example, the auditory signal member may be active during the entire scan sequence, while the tactile signal member is recognizable only during the last step of the scan.

Moreover, the signal member may also provide some tactile information if the auditory signal member comprises at least one flexible member and at least one impact member. Thereby, during the rotation of the rotation drive mechanism, the impact member acts on the flexible member to quickly collide with the surface, thereby generating sound, as well as providing vibrotactile information.

The apparatus may be arranged to have additional signal elements, and in particular the rotational drive mechanism may be configured to visually indicate to the user the progress of the scan so that progress of the scan through at least one opening provided in the distal end surface of the housing is visible And may further comprise a visual signal member configured. In this way, the user is also provided with visual information regarding the progress of the scan.

As with the signal elements mentioned above, the visual signal member may also include at least one indicator element for informing the user that the device is ready for drug injection, the drug injection is in progress, and that the drug injection has ended have.

These and other aspects of the present invention and advantages of the present invention will become apparent from the following detailed description of the invention and from the accompanying drawings.

In the following detailed description of the present invention, reference will now be made to the accompanying drawings.

1 is a perspective view of a scanning apparatus according to a first preferred embodiment of the present invention,
FIG. 2 is a first exploded view of a scanning apparatus according to the first preferred embodiment of FIG. 1,
Figure 3 is a further exploded view of a scanning device according to a first preferred embodiment of the present invention,
4 is a further exploded view of a scanning device according to a first preferred embodiment of the present invention,
Figure 5 illustrates additional components of a scanning device according to a preferred embodiment;
Figure 6 illustrates additional components of a scanning device according to a preferred embodiment;
Figure 7 is a cross-sectional view of a scanning device according to a preferred embodiment of the present invention in an initial position,
Figure 8 is a perspective view of a scanning device according to a preferred embodiment of the present invention in an initial position as shown in Figure 7;
9 is a perspective view according to a second preferred embodiment of the present invention,
Figure 10 is a perspective view of the details of the second preferred embodiment,
11 is a perspective view of the details of the second preferred embodiment,
Figure 12 is a perspective view of the details of the second preferred embodiment,
Figure 13 is a perspective view of the details of the second preferred embodiment,
14A and 14B are detailed sectional views of a tactile display device according to a second preferred embodiment;

1 shows a perspective view of a scanning apparatus according to a first preferred embodiment of the present invention. The scanning device 1 has a housing including a proximal housing portion 2, a distal housing portion 3, a proximal intermediate housing portion 4 (FIG. 2), and a distal intermediate housing portion 5. In the assembled state of the scanning device 1, the proximal housing portion 2, the distal housing portion 3, and the distal intermediate housing portion 5 form the outer surface or appearance of the scanning device 1.

As shown in Figure 1, the proximal housing portion 2 includes at least one window 6. In a preferred embodiment, two such windows are provided and provided on opposite sides of the proximal housing part 2. [ Such a window allows the user to observe the state of the scan, i.e. whether the scanning device 1 is still in its initial stage with the drug still not scanned, or whether the drug container has already been emptied. Through the window (6), the user can see the drug container contained in at least the proximal housing part (2).

Figure 2 also shows the front cap 7 which closes the proximal opening of the proximal housing portion 2 until the scanning device 1 is used.

In Fig. 1, the outer end 41 of the spring can also be seen. This will be described in more detail below.

Figure 2 shows a first exploded view of a scanning device 1 according to a first preferred embodiment of the present invention. In this exploded view of Figure 2, the front cap 7 as well as the proximal housing portion 2, the distal intermediate housing portion 5 and the distal housing portion 3 are shown "removed" Figure 2 also shows the proximal intermediate housing portion 4. The proximal intermediate housing part 4 forms part of the housing of the scanning device 1 but is in fact connected to the proximal housing part 2 and the distal intermediate housing part 5 As shown in FIG. To this end, the outer surface of the proximal middle housing portion 4 and the inner surface of the proximal housing portion 2 and the distal intermediate housing portion 5 are provided with circumferential groove-ribs like groove-rib structure is provided. The proximal housing portion 2 and the distal intermediate housing portion 5 can be easily snap engaged onto the proximal intermediate housing portion 4 so that the proximal housing portion 2 and the distal intermediate housing portion 5 can be snap- It does not fall. However, the connection between these parts can be releasable, so that the drug container can be inserted into or removed from the proximal portion of the scanning device 1. [

2, the injection apparatus according to the first embodiment of the present invention includes a drug container holder 10. In this embodiment, In the fully assembled state of the injection device 1, the drug container holder 10 is at least a proximal portion thereof located in the proximal housing portion 2. [ This will be described in more detail below with reference to FIG. In the preferred embodiment shown in FIG. 2, the drug container holder 10 includes first and second container holder guides 11. Preferably, the container holder guide 11 is arranged on the opposite sides of the container holder 10 and extends in the longitudinal direction thereof. The container holder guide 11 is received in a corresponding groove structure provided on the inner surface of the proximal housing part 2 so that the drug container holder 10 is movable axially with respect to the housing but with respect to the housing, (2).

Figure 2 also shows a needle shield sleeve 17 having a needle shield sleeve extension 18 at its proximal end. At its distal end, the needle shield sleeve 17 comprises two tongue extensions 19 arranged in opposite positions with respect to the longitudinal central axis of the scanning device 1. [ The proximal portion of the needle shield sleeve 17 is generally cylindrical in shape. Recently, the upper part is a completely closed cylinder from which two tongue extensions 19 project and extend towards the distal end of the scanning device 1. In the preferred embodiment shown in the figures, the tongue extension 19 basically comprises three regions. The first, nearest top region 191 is formed by two cylindrical segments having the same radius / diameter as the closest cylindrical top portion of the closed sleeve 17 of the needle. The distal portion or region 193 of the tongue extension 19 is spaced from one another by a distance greater than the diameter of the cylindrical portion. Between these two regions is provided an intermediate region 192 that forms a transition between a smaller diameter of the cylindrical region 191 and a greater distance at the distal end 193 of the tongue extension 19. Generally, the needle shield sleeve 17 has a wider configuration in that it extends from its proximal end toward its distal end.

2 further shows a proximal housing spring retainer 30 which is generally ring-shaped or substantially ring-shaped and arranged coaxially with the proximal housing part 2. [ The proximal housing spring retainer 30 surrounds the distal region of the drug container holder 10, i.e., radially between the distal region of the drug container holder 10 and the distal region 193 of the tongue extension 19, Is located as shown in FIG. 4, the proximal housing spring retainer 30 is configured such that when the injection device 1 is removed from the injection site after drug delivery has been performed to cover the needle 13, (Not shown in Fig. 2) to push the needle sleeve 17 toward the end of the needle sleeve.

Fig. 2 also shows the container driver locking means 25, which is a generally ring-shaped element. The container drive locking means 25 is rotatable with respect to the housing and engages the needle shield sleeve 17. This engagement is described in more detail below with reference to Figures 3 and 4.

On the circle from the vessel actuator locking means 25, the vessel actuator 32 is located. The vessel actuator 32 is arranged to be connectable to the vessel holder 10, which will be described in more detail below.

2 also shows a first energy accumulation member, i.e., a first spring 40, used to perform the scan, and a second spring 40 for axially moving the drug container holder 10 to perform needle penetration prior to injection of the drug For example, a second spring 45, which is used.

Finally, Figure 2 shows an indicator 80 for indicating the end of administration.

The additional components shown in Figure 2, which are not discussed yet, will be discussed in detail below.

Figure 3 shows a further exploded view of the scanning device 1 according to a preferred embodiment of the present invention.

In Fig. 3, the needle shield sleeve 17, the needle shield sleeve extension 18, and the container driver locking means 25 are shown "removed" from the scanning device assembly. In addition, the proximal intermediate housing portion 4 and the first spring 40 are shown in greater detail as discrete components.

In Figure 3, one of the two opposed grooved structures 26 of the vessel actuator locking means 25 is shown in greater detail. Each groove structure 26 has two segments, an inclined groove 261 and a longitudinal groove 262. A radial projection 20 formed in the inner surface of the distal region 193 of the tongue extension 19 is located in the sloped groove 261 of the groove structure 26 at the initial position of the scanning device 1. [ The needle shield sleeve 17 is pushed or moved toward the distal end of the scanning device 1 when the scanning device 1 is disposed on the injection site, for example the user's skin. Such displacement of the needle shield sleeve 17 causes the protrusions 20 to move in the grooves 261 inclined toward the distal end of the vessel actuator locking means 25 (Shown in Figure 261). Since the vessel drive locking means 25 is rotatable relative to the housing (in that it abuts the vessel actuator 32) but is fixed in the longitudinal direction and the needle shielding sleeve is rotationally locked, The longitudinal displacement of the needle shielding sleeve 17 towards the distal end of the sloped groove 1 causes a rotational movement of the vessel actuator locking means 25 such that the projection 20 is slid toward the distal end of the sloped groove 261, .

The protrusion 20 remains at the distal end of the groove structure 26 as long as the injection device is pressed against the injection site, i. E. The needle shield sleeve 17 is held in its distal position. However, for example, after drug delivery, when the user removes the scanning device 1 from the injection site, the needle shield sleeve 17 is urged toward the proximal end of the scanning device 1 as described above. The protrusion 20 slides along the longitudinal groove 262 and is locked to the proximal end of the longitudinal groove 262 by the respective locking structure 28. [ This prevents the needle shield sleeve 17 from being able to move again toward the distal end of the scanning device 1.

Figure 3 also shows the drug container holder 10 with two container holder guides 11 in more detail. In addition, one of the two pins 31 of the proximal housing spring retainer 30 extending parallel to the longitudinal axis toward the proximal end of the scanning device is shown in its full length.

Figure 3 also shows a rigid needle shield remover 16. The rigid needle shield remover 16 has, at its proximal end, a proximal end (not shown) that engages a corresponding engaging structure on the inner surface of the front cap 7, e.g., a corresponding groove Such as circumferential ribs on the surface. Due to such engagement, the rigid needle shield remover 16 is withdrawn from the medicament container 12 upon removal of the front cap 7. In addition, when the rigid needle shield remover 16 is removed, the flexible portion 14 and the rigid portion 15 (or both) of the rigid needle shield 16 and the rigid needle shield remover 16, due to their respective engaging structures, See FIG. 5) is also removed from the medicament container 12.

Figure 3 also shows the container actuator 32 in more detail. The vessel actuator (32) includes at least one rotating locking rib (39). In the preferred embodiment, four rotary locking ribs 39 are provided, three of which are shown in FIG. In the assembled state of the scanning device 1 the rotary locking ribs 39 are positioned or received in corresponding locking grooves 8 arranged on the inner surface of the proximal intermediate housing part 4. [ The locking ribs as well as the corresponding grooves extend in the longitudinal direction. Such a structure prevents the vessel actuator 32 from rotating, i.e., the vessel actuator 32 is longitudinally movable relative to the housing but is rotationally locked.

On its proximal side, the vessel actuator 32 includes at least one vessel actuator arm 33. In the preferred embodiment shown in the figures, two vessel actuator arms 33 are arranged (see Fig. 4). The container actuator arm 33 includes an engagement opening 34 configured to engage a corresponding engagement projection 36 projecting from a container holder tongue extension 35 provided at the distal end of the container holder 10, respectively. The drug container holder 10 is connected to the container actuator 32 and the longitudinal displacement of the container actuator 32 towards the proximal end of the scanning device 1 (by the second spring 45) Thereby causing movement of the drug holder 10 toward the proximal end of the needle 1, whereby needle penetration is performed.

As can also be seen in FIG. 3, the vessel actuator 32 includes at least one ledge 37. In a preferred embodiment, two legs 37 are provided (as can be seen in more detail in FIG. 4). By these ledges 37 the vessel actuator 32 is initially in contact with the stop rib 27 located on the inner surface of the vessel actuator locking means 25 (the stop rib 27 is shown in Figure 6) . Thus, the container actuator 32 and hence the drug container holder 10 is prevented from moving in the proximal direction at the initial position of the scanning device, i. E. Prior to its use, Because such movement is blocked by the vessel actuator locking means 25 due to the abutment of the valve 37. The stop rib 27 is moved away from abutment with the ledge 37 only during the rotational movement of the container actuator locking means 25 (caused by the distal displacement of the needle shield sleeve 17). Thus, the vessel actuator is no longer locked / blocked in the axial direction by the vessel actuator locking means 25.

Figure 3 also shows the plunger actuator 50, the plunger rod 60, and the plunger drive locking means 70. These components are described in more detail below.

3, the first spring 40 includes an outer end 41 connecting the first spring 40 to the housing, i.e., the distal housing portion 3, and a first spring 40 ) To the plunger driver (50). The outer end 41 can extend, for example, through a longitudinal slit in the distal housing portion so that it can engage the wall in the form of a hook. The first end 41 can then be seen from the outside as shown in Fig. Alternatively, the first end of the spring 40 engages a mating engagement structure provided on the inner surface of the distal housing portion 3. [

In the exploded view of Fig. 4, the scanning device 1 of the preferred embodiment of the present invention is further disassembled. In this figure, the proximal housing spring retainer 30, the container actuator 32, and the plunger drive locking means 70 are shown "removed" from the assembly. In Figure 4, the distal end of the drug container holder 10 is shown uncovered by the container actuator 32. Thus, two container holder tongue extensions 35 each having an engaging projection 36 can be easily seen.

In addition, two opposed arms 33 of the vessel actuator 32 are shown. In a preferred embodiment, each arm includes two portions, a first portion extending in the radial direction and a second portion extending in the longitudinal direction toward the proximal end of the scanning device. Although only two container actuator arms 33 and only two corresponding container holder tongue extensions 35 are shown in the preferred embodiment, the present invention is applicable to a single arm-protrusion pair, or even a single arm-protrusion pair, Such as a larger number of arm-protruding pairs. Similarly, while the vessel actuator 32 may have only a single rotating locking rib 39, the present invention also contemplates a vessel having two, three, five, or six, or even more, Lt; / RTI > 4 also includes only two ledges 37 to abut the vessel driver locking means 25, but only one or three, four, or more ledges Other configurations are also encompassed by the present invention.

Fig. 4 also shows the plunger drive locking means 70. Fig. The plunger drive locking means 70 is a generally cylindrical configuration (distal portion 71) and includes a radial flange 72 at its proximal end. The proximal flange 72 of the plunger drive locking means 70 includes at least one rotational locking element 73 that projects radially. In the embodiment shown in the figures, two such locking elements 73 are provided. By means of these rotary lock elements 73, the plunger drive locking means 70 is initially rotationally locked to the vessel actuator 32. To provide such rotational locking, the vessel actuator 32 includes a corresponding longitudinal rib 75 at the inner surface of its distal portion (shown in FIG. 7). The rotary lock element 73 initially abuts these ribs 75. The axial lengths of these locking ribs 75 of the container actuator 32 are adjusted to the length of the container actuator 32 and the medical container holder 10 is displaced / displaceable to effect needle penetration. More specifically, the axial length of the locking rib 75 is such that, at maximum displacement of the drug container holder toward the injection site, the rotational locking element 73 is finally free from engagement with the locking rib 75. This means that at this stage the plunger drive locking means 70 is no longer rotationally locked by the vessel actuator 32. In other words, when carrying out needle penetration, the container holder 32 is moved in the longitudinal direction relative to the plunger drive locking means 70. The plunger drive locking means 70 is axially locked. Such an axial lock is provided by a locking structure 76 at the distal end of the plunger drive locking means 70 that engages the corresponding structure at the distal end of the distal middle housing portion 5 (see FIG. 7).

Figure 5 shows further components of the scanning device 1 according to a preferred embodiment.

The needle 13 of the medicament container 12 is covered by a rigid needle shield consisting of a flexible portion 14 and a rigid portion 15, as described above.

Figure 5 also shows the plunger actuator 50 which is rotatably locked to the plunger drive locking means 70 but which is axially slidable relative to the plunger drive locking means 70. [ This will be described in more detail with reference to FIG.

The plunger rod 60 shown in FIG. 5 includes at least one longitudinal groove 61 as well as a threaded structure 63. At the proximal end, the plunger rod 60 includes a plunger rod tip 62 into which a spinner element 65 is snap-fitted. The spinner element 65 acts on a stopper in the medicament container 12.

Finally, FIG. 5 shows an indicator assembly for indicating the end of dosing, including an indicator 80 and a U-bracket 81 arranged between the plunger rod 60 and the plunger actuator 50. The U-bracket 81 is connected to the plunger drive locking means 70 such that when the plunger rod 60 is advanced in the proximal direction and is not in contact with the U- 82 are urged in the distal direction. Figure 5 also shows indicator rod 82, which is also part of the indicator assembly. A helical spring (not shown in FIG. 5) is coaxially arranged on the indicator rod 82, wherein the helical spring is arranged in the plunger rod 60. Thus, the indicator rod 82 is received in the central axial through-hole in the plunger rod 60 with the spring, while the U-bracket 81 has its two legs on two opposing longitudinal grooves, Is positioned at 90 degrees with respect to two opposing longitudinal grooves 61 of the plunger rod 60.

Figure 6 shows the plunger driver 50. [ The plunger driver 50, in the illustrated embodiment, includes two internal longitudinal ribs 51. These longitudinal ribs 51 interact with the longitudinal grooves 61 on the outer surface of the plunger rod 60. Thus, the plunger rod 60 is rotatably locked to the plunger actuator 50, but it can slide axially along these ribs 51.

The plunger actuator 50 further includes a longitudinal slit 55 through its wall. By this longitudinal slit 55, the plunger actuator 50 is connected to the inner end of the first spring 40. The force applied to the plunger actuator 50 by the first spring 40 is transmitted to the plunger rod 60 due to the engagement of the internal longitudinal ribs 51 into the longitudinal grooves 61. [

On the other hand, the plunger driver 50 includes at least one external longitudinal rib 52. In the illustrated embodiment, four such ribs are provided spaced apart from one another by 90 [deg.]. The outer longitudinal ribs 52 are slidably received in the longitudinal grooves 74 of the plunger drive locking means 70. The plunger actuator 50 and the plunger rod 60 are urged in such a direction that the force of the first spring 40 is transmitted to the plunger actuator 50 and the plunger rod 60 as long as the plunger drive locking means 70 is prevented from rotating due to the locking engagement with the container actuator 32. [ It is prevented from being rotated even if it acts on the movable member 50. However, once the plunger drive locking means 70 is free to rotate, the plunger actuator 50 and the plunger rod 60 also begin to rotate, which is caused by the first spring 40. The proximal portion of the plunger rod 60 is received in the central opening of the container actuator 32, at the initial stage of the scanning device 1, i.e. before its use. 6, the central opening of the vessel actuator 32 includes a threaded structure 38 that engages the threads 63 of the plunger rod 60. As shown in FIG. Thus, the threaded proximal section of the plunger rod 60 is threadably threaded into the interior of the vessel actuator 32. Due to this threaded engagement, rotation of the plunger rod during use of the syringe device causes axial displacement of the plunger rod towards the proximal end of the syringe device. In other words, the plunger rod 60 is rotated in the direction of the drug container 12 by the thread engagement, and a stopper (not shown) in the drug container holder 12 and abutting on the spinner 65, To release the drug. The torque force of the spring 40 will continue to drive the plunger rod toward the proximal end of the scanning device 1 to pressurize the stopper to release the drug through the needle 13. As the plunger rod continues to move toward the proximal end of the device, the container actuator 32 slides along the plunger rod 60 thereon. The injection is completed when the stopper is at the proximal end of the drug container.

When the plunger rod 60 is fully rotated toward the proximal end of the scanning device 1, the two legs of the U-bracket 81 are no longer supported by the longitudinal grooves of the plunger rod 60. Thus, the radial leg 86 at the proximal end of the U-bracket can be disengaged from the slit in the plunger driver 50. [ A helical spring (not shown) coaxially aligned with the indicator rod 82 causes the indicator assembly to move in a distal direction until the indicator 80 contacts the distal front surface of the distal housing portion 3. This causes the distal projection of the indicator 80 to protrude through the indicator opening 83 provided in the center of the free wall of the distal housing portion 3. This provides the user with a visible and tactile indication that the entire dose has been released.

Figure 7 shows a cross sectional view of a scanning device 1 according to a preferred embodiment of the present invention in an initial position. In particular, FIG. 7 illustrates how the second spring 45 is located within the distal middle housing portion 5. The distal end 46 of the second spring 45 contacts the inner surface of the distal radial wall of the distal intermediate housing portion 5. Alternatively, it may contact the ledge proximal to the distal radial wall of the distal intermediate housing portion 5, provided within the distal intermediate housing portion. On the other hand, the proximal end 47 of the second spring 45 abuts the distal surface of the vessel actuator 32.

The same cross-section is shown in Fig. 8 as a perspective view, but to provide different views of the various components and their interengaging with each other. 8, the relative arrangement of indicator 80, U-bracket 81, indicator rod 82, and syringe distal opening 83 can be seen. The indicator rod 82 extends substantially within the central bore of the plunger rod 60. At the distal end of the scanning device 1 the distal portion of the syringe rod 82 extends beyond the distal end of the plunger rod 60 and is received within the inner central bore of the indicator 80. The indicator rod 82 includes a circumferential flange 84 adjacent its distal end. Viewed in the axial direction, a middle portion of the U-bracket 81 is positioned between the circumferential flange 84 and the proximal surface of the indicator 80. As shown in FIG. 5, the middle portion of this U-bracket 81 includes a through hole through which the distal portion of the indicator rod 82 extends. The two legs of the U-shaped bracket 81 extend in the axial direction toward the proximal end of the plunger rod 60. At its proximal end, the two legs of the U-bracket 81 each include a radial leg 86. These radial legs 86 project into corresponding radial openings in the plunger driver 50 (see FIG. 5).

Figure 9 shows a perspective view of a second preferred embodiment of the present invention. The scanning apparatus 100 shown in Fig. 9 is very similar to the scanning apparatus 1 according to the first preferred embodiment of the present invention. The same components are denoted by the same reference numerals. In the following, only differences between the first preferred embodiment and the second preferred embodiment will be described in detail.

As shown in Fig. 9, the scanning apparatus 100 is different from the scanning apparatus 1 with respect to the indicator assembly provided to show the end of dosing. The structures for needle penetration and drug injection shown in Figs. 2-6 are also present in the scanning device 100 of Figs. 9-12.

The second preferred embodiment shown in FIG. 9 includes an indicator assembly 180 provided at the distal end of the housing. That is, the indicator assembly is preferably positioned on a circle with respect to the plunger drive means (50, 70) and / or on a circle with respect to the first energy accumulation member. The indicator assembly includes a cap 180 that is shown as transparent in an embodiment and has at least one opening 181 with a solid panel 184 disposed within the opening. In the embodiment shown in the figures, four opposed openings 181 are provided. The four openings 181 are opposite with respect to the central axis of the scanning device, that is, they are positioned opposite. Through the transparent cap 180, the user can see signal elements in the form of a rotatable element, such as a wheel or disc 182, also shown in FIG.

As shown in FIG. 11, the rotatable disk 182 includes a cylindrical proximal projection 188, such as a wheel hub. By this wheel hub 188, the rotatable disk 182 is connected to the distal end of the plunger driver 50. Thus, upon rotation of the plunger actuator 50 by the first spring 40, the rotatable disk 182 also rotates. Which may be viewed by the user via tab 180. [ Thus, the user can easily see if the device is operating properly and whether the scan is in progress.

As also shown in FIG. 12, the rotatable disk 182 includes a distal display structure having a plurality of segments 190a, ..., 190i, ..., 190n. These segments 190 are alternating with the radial ribs 192, i.e., separated from each other by a radial rib. The ribs 192 project at least in the distal direction from the surface of the rotatable disk and extend radially about the radial center of the scanning device. As the rotatable disk 182 rotates, alternate structures of the ribs and segments are visible through the cap 180 as they pass through the panel 184. In a preferred embodiment, the segment 190 and / or the rib 192 constitute a visual signal member 190, 192. For example, segment 190 or rib 192 seen through cap 180 at an early stage of scanning device 100 may include a first display element, while segment (s) visible through the cap at the end of the scan 190 or rib 192 may possibly include a second different indicator element so that the user can easily distinguish the initial stage before the scan and the final stage after the injection of the drug. For example, the segment 190 is colored with a different color. Alternatively, each directional width of the segment (not shown in the figures) may be varied from very small to wide in order to distinguish the initial and final positions, for example.

Further, these rotary scanning indicating mechanisms are arranged so that the progress of the scanning is visible through at least one opening provided at least on the distal end surface of the housing.

Additional information devices available to the user are absence of auditory signals. It includes a projection or ledge 194 (Fig. 11) on the proximal-oriented surface of the rotatable disk 182. As shown in Fig. 11, the ledge is generally radially oriented but may be arranged in other directions. These ledges 194 are intended to cooperate with a flexible member 196 arranged on the distal end surface 198 of the distal housing portion 3 (FIG. 12). The flexible member 196 includes at least one (in the illustrated embodiment, two) arms 200 that extend generally coplanar with the surface 198, wherein the free end is a distal inclined surface 202 to form a wedge-shaped, distal-directed projection.

Thus, when the rotatable disk 182 is rotating during the scan as described above, the ledge 194 on the rotatable disk 182 contacts the tilted surface of the projection 202 of the arm 200 , And will urge the arm 200 in the proximal direction until the protrusion 202 is moved away from contact with the ledge 194. This will cause the arm 200 to bend back quickly so that the protrusion 202 of the arm 200 will collide with the proximal-oriented surface of the rotatable disk 180, creating an audible sound. Thus, during rotation of the rotatable disk 182, the arm 200 with the ledge 194 and the protrusions will cause audible sound during the scan sequence until the rotatable disk stops at the end of the scan sequence.

To further provide information to the user during the scanning sequence, the tactile information member is arranged at the distal end of the device. It includes a tactile signal member 204 (Figure 11) having a generally tubular shape. On its inner surface, it is arranged such that the longitudinally oriented ledges 206 (two in the illustrated embodiment) are positioned diametrically opposite each other. These ledges 206 fit into longitudinally extending grooves 208 in the center tab or column 210 attached to the inner surface of the cap 180 and are oriented in a proximal direction, .

In addition, the actuator 204 is arranged with its at least one distally extending protrusion 212 attached to its distal-oriented end surface. In the illustrated embodiment, there are two protrusions 212 on the driver 204. The cap 180 is also arranged with a corresponding number of passageways 214 (FIG. 13) passing through its end surface located on the side of the column 210 of the cap 180. The protrusion 212 of the actuator 204 is positioned such that when the actuator 204 is at its highest position along the column 210 of the cap 180 the protrusion passes through the passageway 214 of the cap 180 and through the cap 180 to a predetermined distance over the distal-oriented end surface of the first, second, The column 210 of the cap 180 has a diameter that is slightly less than the inner diameter of the driver 204 so that the actuator is rotationally locked to the tab as described but may slide along the tab.

The outer surface of the actuator is arranged to have a threaded segment 216, such as, for example, a spirally extending ledge. They cooperate with corresponding threaded or helically extending grooves 218 (Figure 12) on the central passageway of the proximal projection 188 of the rotatable disk 182.

During the scanning sequence, the rotatable disk continues to rotate as described above. On the other hand, the tactile signal member is rotationally locked due to the longitudinal register 206 which fits into the groove 208 of the cap 180, which is eventually fixed with respect to the distal housing portion 3. The rotation of the rotatable disk 182 will thus cause its threaded segment 218 to act on the threaded segment 216 of the tactile signal member 204 thereby causing the tactile signal member 204 to move from its initial position Lt; RTI ID = 0.0 > linearly < / RTI > A linear movement will eventually cause the distal directed projection 212 of the tactile signal member to extend through the passageway 214 and protrude above the surface of the cap 180 (Fig. 14B). Thus, when the patient or the user holds the finger against the distal-oriented end surface of the cap 180 during the scanning sequence, he / she will feel the protrusion 212 ascend from the surface.

Thereby, reliable tactile feel and information on the progress of the scan are obtained. In this regard, it should be understood that the length of the protrusion as well as the initial position of the driver relative to the rotatable disk and the pitch of the thread segment can be varied in many ways to achieve the desired predetermined end result. For example, the protrusion may be positioned immediately below the distal surface of the cap at the beginning of the scanning sequence, whereby the protrusion will provide immediate tactile information from the start of the scanning sequence. On the other hand, the configuration is such that when the tactile signal member reaches the end position, the projection extends through the distal surface of the cap only at the end of the scan sequence, indicating the end of the scan sequence, . ≪ / RTI > In addition, the pitch of the threads of the segments 216, 218 may be configured to achieve a predetermined displacement rate of the tactile signal member during scanning. It should also be understood that when handling the device, auditory and visual information as well as tactile information may be provided and used simultaneously to the user.

While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. It will be understood that variations and modifications can be effected by those skilled in the art within the scope of the following claims. In particular, the present invention includes additional embodiments having any combination of features from the various embodiments described above and below.

Also, in the claims, the word "comprising" does not exclude other elements or steps, and the singular does not exclude a plurality. A single unit may perform the functions of some features described in the claims. In particular, the terms "essentially "," approximately ", "roughly ", and the like in the context of an attribute or value also accurately define or precisely define the attribute, respectively. Any reference signs in the claims shall not be construed as limiting the scope.

It should be understood that the embodiments described above and illustrated in the drawings are only to be considered as non-limiting examples of the invention, and that they may be varied in many ways within the scope of the claims.

Claims (13)

As an injection device,
- housings (2, 3, 4, 5),
- a container holder (10) arranged in the housing, the container holder (10) being configured to receive a medicament container (12), the medicament container (12) Having a needle (13) attached to one end thereof and a stopper sealably and slidably arranged inside the drug container (12) at the other end of the drug container 10),
A drive unit comprising a plunger rod 60 and plunger drive means 50,70, the plunger drive means 50,70 being slidably arranged with respect to the plunger rod 60, 60) Is rotatably locked about the housing (2, 3, 4, 5) and the drive unit is arranged inside the housing of the scanning device (1, 100, 200) Wherein the plunger drive means (50, 70) is configured such that the force of the first energy accumulation member (40) is transmitted to the plunger drive means (50, 70) by the first energy accumulation member And the plunger drive means (50, 70) are releasable, so that due to the output torque from the first energy accumulation member (40), the plunger drive means 50 and 70 and the plunger rod 60 is urged toward the proximal end of the scanning device 1, 100, 200 to perform scanning,
- a scanning indicator device (182, 204, 212) comprising a drive mechanism (182) operatively coupled to a distal end of the plunger drive means (50, 70)
The drive mechanism (182) is a rotation drive mechanism (182) locked to the drive means (50, 70) in the rotational direction,
The rotation drive mechanism 182 includes an auditory signal member 194, 200, 202,
The rotation of the rotation driving mechanism 182 causes the audible signal components 194, 200 and 202 to generate audible sound indicative of the progress of the scanning until the scanning sequence is completed and the rotation driving mechanism is stopped ≪ RTI ID = 0.0 >
Injection device. The method according to claim 1,
The auditory signal member includes at least one flexible member (200, 202) and at least one impact member (194)
During rotation of the rotary drive mechanism, the impact member acts on the flexible member to generate sound as the flexible member quickly collides with the surface
Injection device. 3. The method of claim 2,
The flexible member includes at least one arm (200) coplanar with a distal-oriented surface of the distal housing (3)
The arm includes a free end having a distal tapered surface to form a wedge-shaped, distal-directed projection 202,
Wherein the at least one striking member is arranged to move in contact and non-contact with the distally directed protrusion of the at least one arm during rotation and during subsequent scanning, Including a ledge 194,
Injection device. The method according to claim 1,
The rotational drive mechanism further includes a visual signal member (190, 192) configured to visually display the progress of the scan to a user and to view the progress of the scan through at least one opening provided in at least a distal end surface of the housing doing
Injection device. 5. The method of claim 4,
Wherein the time signal member (190, 192) comprises at least one indicator element for informing the user that the scanning device is ready for drug injection, that the drug injection is in progress, and that the drug injection has ended
Injection device. My 5. The method of claim 5,
The time signal member is a rotatable disk 182
Injection device. 7. The method according to any one of claims 1 to 6,
The tactile signal member includes at least one protrusion (212) projecting outwardly from a distal end surface of the housing, the tactile signal member having a first end and a second end, having a
Injection device. 8. The method of claim 7,
The tactile signal member 204 is provided with a threaded segment 216 configured to cooperate with a corresponding threaded segment 218 on the rotational drive mechanism 182 to drive the tactile signal member 204
Injection device. 9. The method of claim 8,
Wherein the pitch of the threaded segments (216, 218) is configured to achieve a predetermined displacement rate of the tactile signal member
Injection device. My 8. The method of claim 8,
Wherein the length of the at least one protrusion (212) is configured to achieve a predetermined timing and tactile experience with respect to the progression of the scan
Injection device. delete delete delete

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